Danish translation of the PhVWP's recommendation for the product information of gonadotropin-releasing hormone agonists

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for gonadotropin-releasing hormone agonists (buserelin, goserelin, histrelin, leuprorelin, nafarelin, triptorelin). The Danish Medicines Agency has now translated this recommendation into Danish.

The translation is available in the box to the right.

The text is used to prepare new product information. Furthermore, marketing authorisation holders of gonadotropin-releasing hormone agonists (buserelin, goserelin, histrelin, leuprorelin, nafarelin, triptorelin) must implement the new text by submitting variation applications for all relevant products.